GUEST COLUMNISTS

• Pharma Process Validation: Initial Conclusions Are Often Deceptive

  As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.

• 6 Best Practices For Biopharma Talent Management In 2023

  The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.

• 3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully

  Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.

• Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases

  Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.

• Decentralized CAR-T Manufacturing: Reduce Cost/Complexity, Expand Access

  High costs are endemic to CAR T-cell therapy treatments, leading to a large gap in healthcare between those who can afford to pay and those who cannot. However, changes in manufacturing processes — namely decentralizing them — can reduce costs and complexity while also expanding patient access.

• Biomarker Testing: A Key Component To Advancing Precision Medicine

  Biomarker testing isn’t always the standard of care for many people living with cancer today. Providers and patients need to be better educated about biomarker testing, we need a consistent standard of care across oncology institutions, and we need to advocate for equitable access to biomarker testing.

• Biopharma Facility Modular Design & Construction: Key Considerations

  In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.

• Beyond Nuclear Genetics: Let’s Think Differently About CNS Disease Targets

  Nuclear genes with mutations remain the primary focus for selecting biological drug targets, but we have yet to see a drug come to market from a genetically validated target that can arrest or reverse diseases like Parkinson’s. We need to expand our research to explore the essential drivers, genetic or otherwise, that switch our cells from order to disorder or from function to dysfunction.